CILAS

Dealing with clinical documents required by ethics committees, health authorities or market access agencies

• Study synopsis, protocols/CIP and amendments
• Clinical investigation/study reports (CIR/CSR)
• Case report forms (CRF)
• Ethics committees- and health authorities application forms
• Investigator’s brochures (IB)
• Patient brochures
• Patient information sheets
• Patient informed consent forms (ICF)
• Manuals of operations
• Clinical evaluation reports (CER) for medical devices
• Answering to deficiency letters
• Product labelling: summary of product characteristics (SmPC) and instructions for use (IFU)
• Clinical modules of marketing authorisation applications (clinical summary and overview, summary of safety and efficacy) for European notify bodies and FDA

Scope of clinical studies:

• Phases I-IV studies (pharmaceuticals drugs)
• Pilot/pivotal/PMCF studies (medical devices)
• Non-interventional studies/programs (NIS/NIP)
• Registries
• Investigator-initiated trial (IIT)